A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
TerSera Therapeutics LLC
Study ID
NCT07310420
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • ZOLADEX — DRUG
    Participants will receive ZOLADEX as a subcutaneous (SC) injection on Day 1 (Week 1), and Day 85 (Week 12) for a total of 2 treatments.

Study Details

The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).

Key Dates

First listed
Dec 30, 2025
Start date
Aug 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ZOLADEX 10.8 mg
    Participants will receive 10.8 mg ZOLADEX on Day 1 and Day 85.

Primary Outcome Measure

Percentage of Participants with LH Values Below a Specified Threshold at Week 6 [ Time Frame: Week 6 ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Genesis Cancer and Blood InstituteHot SpringsArkansas71913
Stephen Divers, MD
MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Ami Chitalia, MD
Cancer Centers of FloridaOcoeeFlorida34761
Gopal Kunta, MD
Summit Cancer CareSavannahGeorgia31405
Mark Taylor, MD
NorthShore University Health System - Evanston HospitalEvanstonIllinois60201
Poornima Saha, MD
NorthShore University HealthSystem - Evanston HospitalEvanstonIllinois60201
Poornima Saha, MD
Duly Health and CareLisleIllinois60532
Daniel Frank, MD
Orchard Healthcare ResearchSkokieIllinois60077
Ira Oliff, MD
Springfield Clinic - The Cancer CenterSpringfieldIllinois62702
Namita Vinayek, MD
Profound Research LLC at Michigan Hematology and Oncology ConsultantsRoyal OakMichigan48073
Savitha Balaraman, MD
St. Vincent Frontier Cancer Center (SVFCC) - Billings (Frontier Cancer Center and Blood Institute)BillingsMontana59102-6746
Patrick Cobb, MD
San Juan Oncology AssociatesFarmingtonNew Mexico87401
Jeffrey Neidhart, MD
New York Oncology Hematology - Amsterdam Cancer CenterAmsterdamNew York12010
Ami Negandhi, MD
Montefiore Medical CenterEast SyracuseNew York13057
Jinyu Lu, MD
Chelsea Medical Center at Mount SinaiNew YorkNew York10011
Paula Klein, MD
Cleveland Clinic FoundationClevelandOhio44195
Erin Roesch, MD
The Mark H. Zangmeister Center-Mid Ohio Oncology/Hematology, Inc.ColumbusOhio43219
Jeanna Knoble, MD
St. Luke's University Health NetworkBethlehemPennsylvania18015
Maria Hafez, MD
Guthrie Medical GroupSayrePennsylvania18840
Joyson Poulose, MD
Oncology Consultants PAHoustonTexas77030
Ricardo Alvarez, MD

Find similar trials in Hot Springs, AR

By research site
Genesis Cancer and Blood Institute· Hot Springs, ARMedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center· Washington D.C., DCCancer Centers of Florida· Ocoee, FLSummit Cancer Care· Savannah, GANorthShore University Health System - Evanston Hospital· Evanston, ILNorthShore University HealthSystem - Evanston Hospital· Evanston, IL

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